The SENTRY Clinical Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01975090
• Collaborator: Novate Medical (Industry)
• Enrollment: 129
• Locations: 23
• Arm: 1
• Actual Duration (Months): 51
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism; Deep Vein Thrombosis	Device: SENTRY IVC Filter	N/A

Detailed Description

Pulmonary embolism (PE) is a prevalent disease with a significant morbidity and mortality. The estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the United States. It is estimated that PE results in more than 200,000 deaths per year.

Currently there are two types of commercially available IVC filters utilized to prevent PE; permanent and retrievable. Both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (DVT). Retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. In a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%.

There are numerous design features of the SENTRY IVC Filter that are intended to improve on the limitations of available IVC filters and obviate the need for retrieval.

Study Design

• Study Type: Interventional
• Actual Enrollment: 129 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SENTRY IVC Filter The SENTRY IVC Bioconvertible Filter	Device: SENTRY IVC Filter; The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects That Reported Clinical Success [6 Months]

   A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications

Secondary Outcome Measures

1. Number of Participants With IVC Filter Related Complications [6months]

   IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age

2. fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent

3. willing and able to comply with follow-up visit requirements

4. requirement of transient PE protection of < 60 days

5. documented or high risk of PE or DVT

6. inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy

7. IVC diameter compatible with filter diameter

8. IVC length adequate for filter placement

Exclusion Criteria:

1. intellectual impairment preventing understanding involvement in a clinical study

2. hypersensitivity to device components

3. impaired renal function defined as a serum creatinine level of > 2.0 mg/dL

4. active systemic infection

5. life expectancy < 12 months

6. malignancy extending PE risk > 60 days

7. pregnant or plans to become pregnant during study follow-up period

8. participating in another investigational trial that has not reached its primary endpoint

9. known hypercoaguable state

10. inherited or acquired hemostatic disorder

11. history or presence of a caval stent or filter

12. inability to gain femoral or jugular access

13. duplicated or left sided IVC

14. renal vein thrombosis or IVC thrombosis extending to the renal veins

15. jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery

16. spinal irregularity that may interfere with successful device delivery

17. occlusive or free-floating thrombus in the IVC

18. contrast allergy that cannot be adequately pre-medicated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brookwood Medical Center	Birmingham	Alabama	United States	35243
2	University of Alabama	Birmingham	Alabama	United States	35294
3	Stanford Hospital & Clinic	Palo Alto	California	United States	94305
4	Memorial Health System	Colorado Springs	Colorado	United States	80909
5	Hartford Hospital	Hartford	Connecticut	United States	06108
6	University of Florida	Gainesville	Florida	United States	32610
7	Emory University	Atlanta	Georgia	United States	30322
8	Adventist Midwest Health	Hinsdale	Illinois	United States	60521
9	St. Francis Hospital	Peoria	Illinois	United States	61603
10	Indiana University	Indianapolis	Indiana	United States	46202
11	Lakeview Regional Heart Center	Covington	Louisiana	United States	70433
12	Washington University in St Louis	Saint Louis	Missouri	United States	63110
13	Rutgers-New Jersey Medical School	Newark	New Jersey	United States	07103
14	University of North Carolina	Chapel Hill	North Carolina	United States	27599
15	Rex Hospital	Raleigh	North Carolina	United States	27607
16	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
17	Jobst Vascular Institute	Toledo	Ohio	United States	43606
18	Rhode Island Hospital	Providence	Rhode Island	United States	02903
19	University of Texas Southwestern	Dallas	Texas	United States	75390
20	Providence Medical Research Center	Spokane	Washington	United States	99204
21	Imelda Hospital	Bonheiden		Belgium
22	AZ Sint-Blasius	Dendermonde		Belgium
23	Pontificia Universidad Catolica De Chile	Santiago		Chile

Sponsors and Collaborators

• Boston Scientific Corporation
• Novate Medical

Investigators

• Principal Investigator: Michael D Dake, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011 Nov;22(11):1522-1530.e3. doi: 10.1016/j.jvir.2011.08.024. Review.
• Dake MD, Murphy TP, Krämer AH, Darcy MD, Sewall LE, Curi MA, Johnson MS, Arena F, Swischuk JL, Ansel GM, Silver MJ, Saddekni S, Brower JS, Mendes R; SENTRY Trial Investigators. One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter. J Vasc Interv Radiol. 2018 Oct;29(10):1350-1361.e4. doi: 10.1016/j.jvir.2018.05.009. Epub 2018 Sep 1.
• Gaines PA, Kolodgie FD, Crowley G, Horan S, MacDonagh M, McLucas E, Rosenthal D, Strong A, Sweet M, Panchal DK. Sentry Bioconvertible Inferior Vena Cava Filter: Study of Stages of Incorporation in an Experimental Ovine Model. Int J Vasc Med. 2018 Jul 19;2018:6981505. doi: 10.1155/2018/6981505. eCollection 2018.
• Grassi CJ, Swan TL, Cardella JF, Meranze SG, Oglevie SB, Omary RA, Roberts AC, Sacks D, Silverstein MI, Towbin RB, Lewis CA; Society of Cardiovascular & Interventional Radiology, Standards of Practice Committee. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. SCVIR Standards of Practice Committee. J Vasc Interv Radiol. 2001 Feb;12(2):137-41.
• Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M, Cavanaugh KJ Jr. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2013 Oct;1(4):376-84. doi: 10.1016/j.jvsv.2013.04.005. Epub 2013 Jul 4.
• Tsai AW, Cushman M, Rosamond WD, Heckbert SR, Polak JF, Folsom AR. Cardiovascular risk factors and venous thromboembolism incidence: the longitudinal investigation of thromboembolism etiology. Arch Intern Med. 2002 May 27;162(10):1182-9.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01975090
• Other Study ID Numbers: CI 036
• First Posted: Nov 3, 2013
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis

Study Results

Participant Flow

Arm/Group Title	SENTRY IVC Filter
Arm/Group Description	Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
Period Title: Overall Study
STARTED	129
6-month Follow-up	117
COMPLETED	117
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	SENTRY IVC Filter Group
Arm/Group Description	Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation
Overall Participants	129
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	70 54.3%
>=65 years	59 45.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (13.52)
Sex: Female, Male (Count of Participants)
Female	56 43.4%
Male	73 56.6%
Region of Enrollment (Count of Participants)
Belgium	4 3.1%
United States	115 89.1%
Chile	10 7.8%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects That Reported Clinical Success
Description	A Composite Endpoint including: Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SENTRY IVC Filter
Arm/Group Description	The SENTRY IVC Bioconvertible Filter SENTRY IVC Filter: The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval.
Measure Participants	114
Count of Participants [Participants]	111 86%

2. Secondary Outcome

Title	Number of Participants With IVC Filter Related Complications
Description	IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).
Time Frame	6months

Outcome Measure Data

Analysis Population Description

Freedom from IVC Filter Related Complications was assessed by the site and reviewed by an Independent Core Lab. All subjects that had data collected were included in the analysis for population.

Arm/Group Title	Filter Tilting	Filter Migration	Filter Embolization	Filter Fracture	Filter Perforation	Symptomatic Complications
Arm/Group Description	Core Lab reviewed imaging data at 6 month follow-up	Core Lab reviewed imaging data at 6 month follow-up	Core Lab reviewed imaging data at 6 month follow-up	Core Lab reviewed imaging data at 6 month follow-up	Core Lab reviewed imaging data at 6 month follow-up	Symptomatic Complications is the composite of Symptomatic Caval Thrombosis and Other Symptomatic Complications Requiring Invasive Intervention and filter-related death at 6 months
Measure Participants	114	114	114	114	114	126
Number [participants]	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	2 NaN

Adverse Events

Time Frame	6 month adverse events were monitored by Organ Class .
Arm/Group Title	SENTRY IVC Filter
Arm/Group Description	Patients were enrolled with documented deep vein thrombosis (DVT) or PE or at temporary risk of developing DVT or PE, and unable to use anticoagulation.
All Cause Mortality
	SENTRY IVC Filter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SENTRY IVC Filter
	Affected / at Risk (%)	# Events
Total	45/129 (34.9%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	5/129 (3.9%)
Cardiac disorders
Cardiac disorders	9/129 (7%)
Congenital, familial and genetic disorders
Congenital, familial, and genetic disorders	0/129 (0%)
Gastrointestinal disorders
Gastrointestinal disorders	5/129 (3.9%)
General disorders
General disorders and administration site conditions	3/129 (2.3%)
Immune system disorders
Infections and infestations	18/129 (14%)
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications	4/129 (3.1%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders	4/129 (3.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	2/129 (1.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	2/129 (1.6%)
Nervous system disorders	5/129 (3.9%)
Psychiatric disorders
Psychiatric disorders	0/129 (0%)
Renal and urinary disorders
Renal and urinary disorders	5/129 (3.9%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders	9/129 (7%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	0/129 (0%)
Surgical and medical procedures
Surgical and medical procedures	0/129 (0%)
Vascular disorders
Vascular disorders	3/129 (2.3%)
Other (Not Including Serious) Adverse Events
	SENTRY IVC Filter
	Affected / at Risk (%)	# Events
Total	85/129 (65.9%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	13/129 (10.1%)
Cardiac disorders
Cardiac disorders	19/129 (14.7%)
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders	1/129 (0.8%)
Gastrointestinal disorders
Gastrointestinal disorders	19/129 (14.7%)
General disorders
General disorders and administration site conditions	14/129 (10.9%)
Infections and infestations
Infections and infestations	45/129 (34.9%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	8/129 (6.2%)
Investigations
Investigations	8/129 (6.2%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders	22/129 (17.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	12/129 (9.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	6/129 (4.7%)
Nervous system disorders
Nervous system disorders	17/129 (13.2%)
Psychiatric disorders
Psychiatric disorders	7/129 (5.4%)
Renal and urinary disorders
Renal and urinary disorders	16/129 (12.4%)
Reproductive system and breast disorders
Reproductive system and breast disorders	1/129 (0.8%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	26/129 (20.2%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	5/129 (3.9%)
Surgical and medical procedures
Surgical and medical procedures	6/129 (4.7%)
Vascular disorders
Vascular disorders	17/129 (13.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.